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Published on FierceBiotech (http://www.fiercebiotech.com)

FDA, Big Pharma collaborate on genetic tests

By admin
Created Sep 27 2007 - 6:59am

Seven of the world's biggest drug makers are banding together to create a research consortium that will develop genetic tests that can identify patients vulnerable to dangerous adverse events. Under prodding from the FDA, Pfizer, Roche and others will back a research program that will develop tests for serious liver toxicity [1] as well as Stevens-Johnson syndrome. Their work will go into the public domain, available to anyone wishing to develop a genetic test on that data. The development of pharmacogenetics is considered crucial to a new generation of biotech drugs, which are intended to produce higher efficacy rates among smaller groups of patients.

- check out this release [1] for details on the program
- read the article [2] from The New York Times

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PDUFA debate highlights drug safety issues. Report [4]
Senate toughens drug safety supervision in PDUFA bill. Report [4]


Source URL:
http://www.fiercebiotech.com/story/fda-big-pharma-collaborate-genetic-tests/2007-09-27